Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors

Melanoma Stage IV Clinical Trial

Official title:

Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990726
• Other study ID #: 2019-0390
• Secondary ID: NCI-2020-1327420
• Status: Recruiting
• Start date: September 23, 2020
• Est. completion date: February 2, 2027

Study information

• Verified date: September 2023
• Source: M.D. Anderson Cancer Center
• Contact: Noha Abdelwahab Hassan
• Phone: 713-745-4516
• Email: nahassan[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the immune related toxicity and symptom burden in chronic cancer survivors with melanoma who are receiving adjuvant immunotherapy with immune checkpoint inhibitors. Information collected in this study may help doctors to learn more about the side effects caused by immunotherapy, and to learn if there are any relationships between these side effects and immune and genetic biomarkers found in the blood that may be related to patient's reaction to immunotherapy.

Description:

PRIMARY OBJECTIVES:

I. Determine the detailed clinical characterization including timing, severity, and phenotype of immune related adverse events (irAEs) in chronic survivors with melanoma from initiation of adjuvant checkpoint inhibitors (CPI) therapy through 24 months of follow-up.

II. Longitudinally assess patients-reported outcomes (PROs) that measure symptom burden (such as fatigue, depression, sleep disturbance) and quality of life (QOL) in those patients, compared to patients with similar disease stage who opt for active surveillance.

SECONDARY OBJECTIVES:

I. Longitudinally evaluate the correlation of changes in immune analysis (immune cells and cytokines) in peripheral blood samples with timing, severity, and phenotype of irAEs, symptom burden, and QOL in those patients, compared to patients with similar disease stage who opt for active surveillance.

II. Determine whether specific immune-related genetic polymorphisms are associated with the development of irAEs and symptom burden in melanoma patients receiving adjuvant CPI therapy.

OUTLINE:

Patients undergo medical assessments and blood sample collection, and complete questionnaires at baseline, 1 (optional), 3, 6, 12, 18, and 24 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years of age

• Surgically resected stage II, III, or IV melanoma with no evidence of disease according to the American Joint Committee on Cancer (AJCC) classification criteria

• Eligible for adjuvant CPI treatment per treating physician discretion

• Plan to continue care at MD Anderson Cancer Center (MDACC)

• Ability to communicate and read in English language

Exclusion Criteria:

• Previous systemic therapy for melanoma

• Previous history of other cancers treated with immunotherapy

• Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded

• Previous cancer that has been resected two or more years ago are not excluded.

• Previous history of inflammatory or autoimmune diseases. This include but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or psoriasis. Patients with autoimmune thyroid disease, vitiligo, and type I diabetes mellitus are not excluded.

• Other concurrent malignancies that require active therapy

• Participants < 18 years of age and pregnant women are not eligible to participate in this study

Related Conditions & MeSH terms

• Clinical Stage III Cutaneous Melanoma AJCC v8
• Melanoma
• Melanoma Stage IV
• Melanoma, Stage II
• Pathologic Stage III Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Pathologic Stage IIID Cutaneous Melanoma AJCC v8
• Skin Neoplasms

Intervention

Behavioral:
• Assessment
Undergo medical assessments

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detailed clinical characterization	Will determine the detailed clinical characterization including timing, severity, and phenotype of immune related adverse events (irAEs) in chronic survivors with melanoma from initiation of adjuvant checkpoint inhibitor (CPI) therapy through 24 months of follow-up. The primary end point will be at 12 months, but patients will be followed for up to 24 months. Will estimate the incidence rates of any de novo grade 2 or higher irAEs at 12 months post treatment initiation along with 95% confidence interval within the case group. Will also summary irAEs by their onset time in relation to treatment initiation (acute irAE vs late irAE) and by CPI type. Descriptive statistics will be used to summarize results.	24 months
Primary	Patients-reported outcomes (PROs)	Will compare PROs at 12 months between the case (with and without irAEs) and control groups. To compare differences between cases and controls, will use logistic regression to adjust for age, gender, ethnicity, tumor stage and type of CPI therapy. The primary outcome measures include quality of life, depression, and fatigue. Will compare each of the three primary outcomes at a significant level of 0.017 (0.05/3) using Bonferroni multiple comparison adjustment. Will use linear mixed effect models to fit the longitudinal PRO assessments to study the change of PROs over time taking the intra-patient correlation into account and to determine the effect of each of the covariates (relevant patient's demographic, irAEs, clinical and treatment characteristics) on the outcomes.	24 months
Secondary	Changes in immune analysis	Will longitudinally evaluate the correlation of changes in immune analysis in peripheral blood samples with timing, severity, and phenotype of irAEs, symptom burden, and quality of life in those patients, compared to patients with similar disease stage who opt for active surveillance.	24 months
Secondary	Immune-related genetic polymorphisms	Will determine whether specific immune-related genetic polymorphisms are associated with the development of irAEs and symptom burden in melanoma patients receiving adjuvant CPI therapy.	24 months

External Links

•   M.D. Anderson Cancer Center